Status:
COMPLETED
Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Prostate Cancer
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
Prostate cancer is currently the second most common cause of cancer death in men in Western countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and is classically i...
Eligibility Criteria
Inclusion
- Prostate Cancer patients with intermediate or high risk and with indication of radical prostatectomy and LND
- Absence of bone metastasis or other organ imaging test (MRI or scintigraphy)
- Absence of hormone treatment
- Absence of radiotherapy
- Signing an informed consent
- Availability and adequacy of lymph node tissue samples to perform the immunohistochemical
Exclusion
- Life expectancy less than 10 years
- Absence of clinical conditions for the procedure
- Laparoscopic or perineal surgery
- Presence of bone or visceral metastasis
- Neoadjuvant treatment
- Another malignant neoplasia
- Prior abdominal or pelvic surgery
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01812902
Start Date
February 1 2012
End Date
April 1 2018
Last Update
May 14 2018
Active Locations (1)
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1
Instituto do Cancer do Estado de São Paulo
São Paulo, Brazil, 01246-000